Home > Products > Surgery & Tissue Repair > Mesh Surgical-Preshape mesh
- Product Description and Intended Use
- Indications and Scope of Use
- Contraindications and Warnings
- Precautions and Usage Information
Instructions for Use
Failure to follow these instructions may result in improper device performance and/or patient injury.
These instructions provide general guidance for the use of non-absorbable monofilament polypropylene mesh intended for the surgical repair of
hernias and abdominal wall defects.
They are not a comprehensive reference for surgical techniques used to treat these conditions. The product is intended for use only by surgeons
who havereceived specialized training in the treatment of abdominal wall defects.
Description
This product is a non-absorbable monofilament polypropylene mesh intended for the surgical repair of hernias and abdominal wall defects through
extraperitoneal placement.
Instructions
The mesh is intended for the surgical repair of hernias and abdominal wall defects. Correct orientation and placement are essential to ensure use in
accordance with the instructions for use.
Do not implant the mesh intraperitoneally in contact with the intestines or other visceral tissues.
The product is available in various pre-shaped mesh configurations. Applications listed in the instructions for use include:
P3 Evolution, P3 Evolution B
Intended for inguinal hernia repair, with pre-shaped configurations for male patients (with an opening), female patients (without an opening), and
other inguinal hernia repair applications.
TP Dimensional Plug B
A flat, circular mesh intended for inguinal hernia repair, with configurations for male patients (with an opening), female patients (without an opening)
, and other inguinal hernia repair applications.
P3 Basic, P3 Rigid, P3 Medium
Intended for inguinal hernia repair in male patients (with an opening) and female patients (without an opening), with different pre-shaped
configurations depending on the model.
TP Basic
A flat, circular mesh with a pre-shaped design for the relevant hernia repair applications.
P3 T Evolution, T Evolution, TB Evolution
Intended for inguinal and femoral hernia repair, with different three-dimensional mesh plugs and pre-shaped structures depending on the model.
P3 T Soft Mesh, T Soft Mesh, TB Soft Mesh
Pre-shaped meshes with varying weights and pore designs, intended for inguinal and femoral hernia repair as specified in the instructions for use.
KP3MR Series
Includes meshes with varying densities, weights, and pore designs. Some configurations incorporate flat meshes of different sizes.
TPC, TPE
Feature a flat mesh plug design for inguinal and femoral hernia repair as specified in the instructions for use.
Contraindications
．Do not place the mesh in contact with the intestines or other organs, as this may cause severe adhesions.．Do not use in patients who are still growing, pregnant patients, or patients planning to become pregnant.
．Do not use on infected or eroded tissue.
Warnings
．For use only by physicians trained in the use of this product.．The product is supplied sterile. Inspect the packaging to ensure that it is intact before use.
．The physician and other users must visually inspect the packaged product for damage to the sterile barrier.
．Do not use if the packaging has been opened or damaged, as sterility may be compromised.
．Do not use after the expiration date.
．The product is intended for single use in one patient only. Do not resterilize or reuse.
．Ensure correct orientation and positioning of the product.
．The mesh must not come into contact with visceral organs, to avoid serious complications.
．Potential complications associated with mesh use include bowel obstruction, adhesions, damage, migration, fistula formation, erosion, seroma
, hematoma, inflammation, and infection.
．If infection or migration occurs, removal of the mesh may be necessary.
．Select the appropriate mesh size for the defect to avoid recurrence.
．Use of any mesh in a contaminated surgical field may result in fistula formation and/or require mesh removal.
．Handle the product carefully during insertion and positioning to avoid damaging it.
．Patients must notify their physician immediately if they develop fever, wound redness and/or swelling, bleeding, or any other new postoperative
symptoms.
Surgical Use
For use only by physicians trained in the use of this product.
This product is a non-absorbable implantable medical material intended for use only in the operating room.
Mesh size selection must take into account good surgical practice, the size of the defect, the potential for mesh shrinkage, and the condition and pathology
of the patient’s tissue.
Mesh fixation must follow the procedures specified for the fixation system and good surgical practice.
If removal is necessary, the surgeon must follow good clinical and surgical practice and perform appropriate procedures to ensure patient safety.
Use and Placement
Correct orientation is essential to ensure the product’s intended function.
The polypropylene mesh surface must not come into contact with the intestines or other visceral tissues.
Precautions
．Open the packaging in the operating room in accordance with good surgical practice.
．Once the packaging has been opened, do not resterilize or reuse the product.
．Store in a clean, dry place, away from light and heat sources.
．Handle the product using sterile gloves and sterile instruments.
．Physicians must follow good clinical practice and advise patients on postoperative activities and precautions to take during daily activities.
．For at least 30 days after surgery, patients must avoid heavy lifting, straining, and sports activities that engage the abdominal wall.
Adverse Reactions
Potential adverse reactions include obstruction, adhesions, damage, migration, fistula formation, erosion, seroma, hematoma, inflammation, infection, and
hernia recurrence.
Other adverse reactions associated with surgery include pain, bleeding, and surgical failure.
As with other medical devices, the product may cause wound-related complications and/or a foreign body reaction.
As with any foreign material, polypropylene mesh may exacerbate an existing infection. In such cases, removal of the product may be necessary.
Sterilization
All meshes are intended for single use and are sterilized with ethylene oxide (ETO).
Do not use if the packaging is damaged.
Traceability
Each box includes an identification label for product traceability in accordance with applicable regulations.
Disposal
After use, dispose of the product and its associated packaging in accordance with hospital procedures or applicable local regulations.
Shelf Life
The product has a shelf life of 5 years.
Packaging
Each commercial box constitutes one sales unit. Products contained within the box must not be sold individually.
Any small particles present within the packaging do not constitute mobile, suspended foreign matter.
